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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AVANCE CARESTATION CS2; GAS-MACHINE, ANESTHESIA

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DATEX-OHMEDA, INC. AVANCE CARESTATION CS2; GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number CS2+
Device Problem Loss of Power (1475)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/25/2016
Event Type  malfunction  
Event Description
Upon waking the patient, the ventilator simply stopped.The patient was hand ventilated while a second machine was brought into the room.No problems; everything went smoothly.The first machine was removed/tagged, and clinical engineering was notified.Electronic board is being replaced at this time.
 
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Brand Name
AVANCE CARESTATION CS2
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
MDR Report Key6036290
MDR Text Key57714252
Report Number6036290
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCS2+
Device Lot NumberOCU43736
Other Device ID NumberPART#1011-3004-000-REVZAA C00
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2016
Event Location Hospital
Date Report to Manufacturer09/29/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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